Biosimilars have been slow to enter the US market for complex reasons ranging from the manipulation of patent protections to brand-name drug rebates. Now a new analysis, published in the Mayo Clinic Proceedings, suggests that a “high testing bar” for biosimilars to gain regulatory approval is another contributing factor.
The analysis found that the median time from the start of a Phase I study to approval by the US Food and Drug Administration (FDA) was more than 5 years.
In 2010, US lawmakers sought to speed the entry of biosimilars through the passage of the Biologics Price Competition and Innovation Act (BPCIA), which created an abbreviated approval pathway for products that could demonstrate high similarity to originator biologics without clinical differences in safety, purity, and potency.
But the legislation has not brought a flood of biosimilars to the market. As of 1 May 2020, the FDA has approved just 26 biosimilars, of which 17 products have been marketed. In contrast, the European Medicines Agency has approved 64 biosimilars through its abbreviated pathway program, which was created 6 years before the BPCIA…